Vasotop palatable 1,25mg 28 tablets

VASOTOP 

ACEI oral tablets

Laboratory

MSD ANIMAL HEALTH

PHARMACEUTICAL FORM

Oral tablet (Comp.o.)

COMPOSITION BY COMPRESSION:

Vasotop P 0,625 mg Tablets for Dogs:

Active substance: Ramipril 0,625 mg.

Excipient (dye): brown ferric oxide (E 172) 1,0 mg.

Vasotop P 1,25 mg Tablets for Dogs:

Active substance: Ramipril 1,25 mg.

Vasotop P 2,5 mg Tablets for Dogs:

Active substance: Ramipril 2,5 mg.

Excipient (dye): Ferric oxide yellow (E 172) 0,5 mg.

Vasotop P 5 mg Tablets for Dogs:

Active substance: Ramipril 5 mg.

Excipient (dye): red ferric oxide (E 172) 0,250 mg.

INTERACTIONS AND INCOMPATIBILITIES

• Diuretics and low sodium diets potentiate the action of ACE inhibitors by activating the renin angiotensin aldosterone system (RAAS). High doses of diuretics and low sodium diets should therefore be avoided during ACE inhibitor therapy to prevent hypotension (with symptoms such as apathy, ataxia and, more rarely, syncope or acute renal failure).

• Avoid concomitant administration of potassium or potassium-sparing diuretics due to the risk of hyperkalemia.

INDICATIONS

Dogs: Treatment of congestive heart failure (decompensation degrees II, III and IV according to the New York Heart Association NYHA classification) caused by valvular insufficiency due to chronic degenerative valvular heart disease (endocarditis) or cardiomyopathy, with or without add-on therapy with the diuretic furosemide and/or the cardiac glycosides digoxin or methyldigoxin.

Classes and symptoms:

Class II: Fatigue, shortness of breath, cough, etc. which becomes evident when the ordinary exercise is exceeded. Ascites may appear at this stage.

Class III: Stable at rest, but exercise tolerance is minimal.

Class IV: No exercise tolerance. Clinical signs of disability are present even at rest.

In dogs treated simultaneously with Vasotop P and furosemide, the dose of the diuretic may be reduced to achieve the same diuretic effect as would be achieved with furosemide alone.

CONTRAINDICATIONS

• Do not use in dogs with hemodynamically relevant stenosis (eg aortic stenosis, mitral valve stenosis) or obstructive hypertrophic cardiomyopathy.

• Do not use in cases of hypersensitivity to the active principle or to any of the excipients.

ADVERSE REACTIONS

Rarely, a drop in blood pressure may occur at the initiation of ACE inhibitor therapy or following a dosage increase, which may manifest as fatigue, lethargy, or ataxia. In such cases, treatment should be interrupted until the dog's normal condition has returned and then start at 50% of the initial dose. As high doses of diuretics can also lead to a drop in blood pressure, simultaneous administration of diuretics in the first phase of ACE inhibitor therapy should be avoided in these dogs.

ROUTE OF ADMINISTRATION

Orally.

POSOLOGY

Dogs: The therapeutic dose corresponds to a single daily dose of 0,125 mg of ramipril per kg bw (1 Vasotop P 0,625/1,25/2,5/5 mg tablet per 5/10/20/40 kg of weight) .

To ensure an accurate dosage, the dog must be carefully weighed before the dose is calculated.

• Treatment should always start with the lowest recommended dose. The dose should only be increased if the animal does not respond to the recommended starting dose of 0,125 mg per kg bw.

• Depending on the severity of pulmonary congestion in dogs with cough or pulmonary oedema, the dose may be increased after 2 weeks to 0,25 mg ramipril per kg bw per day.

SPECIAL PRECAUTIONS

• If signs of apathy or ataxia (potential symptoms of hypotension) appear during treatment with the product, this should be interrupted and resumed with 50% of the initial dose once the symptoms have subsided.

• The use of ACE inhibitors in dogs with hypovolemia/dehydration (eg as a result of diuretic treatment, vomiting, or diarrhea) may lead to acute hypotension. In such cases, the fluid and electrolyte balance should be immediately restored and treatment with this product discontinued until it has been stabilized.

• In dogs at risk of hypovolaemia, the product should be administered gradually over one week (starting with half the normal dose).

• One to two days before and after starting treatment with ACE inhibitors, the animal's renal function and hydration status should be checked. This is also necessary after increasing the dose of Vasotop P or if a diuretic is administered simultaneously.

• In dogs with renal and hepatic failure, use according to the benefit/risk assessment.

• In dogs with renal disorders, renal function must be monitored during therapy with the product.

• Wash hands after use.

• In case of accidental ingestion, consult a doctor immediately and show him the text of the container or the leaflet.

Use during pregnancy or lactation:

• Since there is no information available on the use of the product during pregnancy and lactation, the product should not be administered to pregnant or lactating females.

PRESERVATION MODE

Do not store at temperatures above 30 °C. Store in a dry place. Close the container well with its lid after each use. Do not remove the desiccant capsule.

OBSERVATIONS

Veterinary use. Medicine subject to a veterinary prescription.

FORMATS

VASOTOP® P 0,625 mg Tablets for Dogs CN 575356 N. Reg.1619 ESP

VASOTOP® P 1,25 mg Tablets for Dogs CN 575359 N. Reg.1295 ESP

VASOTOP® P 2,5 mg Tablets for Dogs CN 575362 N. Reg.1296 ESP

VASOTOP® P 5 mg Tablets for Dogs CN 575365 N. Reg. 1297 ESP

TECHNICAL SHEET